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510(k) K142564

Device
JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4)
Applicant
JMS North America Corporation
510(k) number
K142564
Product code
FIE  
Decision
Substantially Equivalent (SESE)
Decision date
2014-12-23
Date received
2014-09-11
Regulation
876.5540
Classification name
Needle, Fistula
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Sho Hosoki
Address
22320 Foothill Blvd. Suite 350 Hayward CA US 94541 94541

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FIE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251877JMS CAVEO A.V. Fistula Needle SetJMS North America Corporation2025-08-15
K213015DORA Disposable A.V. Fistula Needle SetsBain Medical Equipment (Guangzhou) Co., Ltd.2022-04-08
K171505Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series)Dimesol, Inc.2018-05-17
K163025DORA Disposable A.V. Fistula Needle SetsBain Medical Equipment (Guangzhou) Co., Ltd.2017-07-20
K151017JMS Harmony A.V. Fistula Needle SetJMS North America Corporation2015-05-13
K131950ANGEL TIP SAFETY INTRAVASCULAR NEEDLE SETSummit International Medical Technologies, Inc.2015-01-16
K134019MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECTOR, MEDISYSTEMS ONESITE DUAL LUMEN BUTTONxstage Medical, Inc.2014-09-11
K112734APLAN A.V. FISTULA NEEDLE SETAplan Well Enterprise Co., Ltd.2012-04-24
K112178JMS APHERESIS NEEDLE SET WINGEATER(R) V2JMS North America Corporation2011-10-27
K111948WINGEATER V2JMS North America Corporation2011-10-24
K110157SYSLOC MINI V3JMS North America Corporation2011-02-11
K100520NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVERNipro Medical Corporation2010-03-17
K093637JMS BLUNT A. V. FISTULA NEEDLE SET WITH SITE PREPARATION TOOL MODEL 820-5300, 820-6300 AND 820-7300Jms North America Corp.2010-02-09
K093985NIPRO SAFETOUCH LOCKTAIL SAFETY FISTULA NEEDLENipro Medical Corp.2010-01-22
K082882A.V. FISTULA BLUNT NEEDLE SETJms North America Corp.2009-01-21

Legacy Summary#

summary

FDA Review#

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